Supervisor, QC Data Review

Catalent Pharma Solutions•Baltimore, MD

1d•Onsite

About The Position

Catalent is a leading global CDMO partnering with pharma and biotech innovators to accelerate development and delivery of life-changing therapies. Our FDA-licensed, state-of-the-art CGMP gene therapy campus in Harmans, MD—just minutes from BWI Airport—features EMA and FDA-approved manufacturing suites, fill/finish capabilities, labs, and warehousing to support Phase 3 through commercial production of advanced therapies, including AAV and other viral vector-based products. The Supervisor, QC Data Review is responsible for leading QC Data Reviewers and overseeing the review, approval, and management of data generated within QC. This position will lead the following areas: data review of QC assays, oversight of routine release and stability testing documentation. The Supervisor, QC Data Review will report to the Manager of QC Cell Culture and Data Review.

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry, or a related scientific discipline with a minimum of 6 years of experience in a cGMP QC/QA environment, OR Master’s degree in a related scientific discipline with a minimum of 4 years of cGMP QC/QA experience.
0 – 2 Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict.
Strong experience working in a cGMP Quality Control environment, including review of analytical test methods, validation documentation, data packages, and investigation of suspect or out‑of‑trend results.
Demonstrated use of quality tools such as SPC, Root Cause Analysis, FMEA, 5 Whys, HACCP, and strong technical writing capabilities.
Excellent organizational skills and attention to detail, with strong proficiency in Microsoft Office and the ability to manage work successfully in a dynamic, team‑oriented environment.
Strong verbal communication skills with internal teams and external clients or vendors, and the ability to work an assigned shift.

Nice To Haves

Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Responsibilities

Supervise day‑to‑day operations of the assigned QC Data Review function, including workload planning, prioritization, and execution.
Oversee performance of direct reports by monitoring quality of work, productivity, training status, and adherence to cGMP and safety expectations.
Perform and provide expert guidance on QC data review activities, including verification of results, calculations, documentation accuracy, and compliance with approved methods, SOPs, protocols, and specifications.
Lead troubleshooting and problem‑solving efforts related to data review findings, QC testing workflows, and documentation issues.
Ensure all QC data review activities comply with applicable ISO, USP, EU, CFR, cGMP, and GLP requirements, maintaining a constant state of audit readiness.
Serve as lead support during regulatory and customer audits, including preparation and presentation of data review records, documentation, and data integrity evidence.
Author, review, and approve controlled documents such as SOPs, forms, templates, and support non‑routine protocols, validation plans, and reports.
Lead investigations, change controls, QCAs/CAPAs, data trending, and continuous improvement initiatives related to QC data review processes.
Provide training and oversight to ensure staff are fully qualified in cGMP documentation practices, safety requirements, and new or revised data review procedures.
Communicate effectively with QC leadership, cross‑functional partners, and management, while maintaining flexibility to support off‑hour, weekend, or holiday testing timelines as required.
Other duties as assigned by management.